FDA approves BeiGene esophageal cancer drug

March 15, 2024

The FDA has granted approval to BeiGene's Tevimbra (tislelizumab-jsgr), for treating adults with advanced or metastatic esophageal squamous cell carcinoma (ESCC) following prior systemic chemotherapy.

The nod marks the first U.S. indication for Tevimbra, expected to be available in the latter half of 2024. Tevimbra’s approval was supported by the results of the global phase 3 RATIONALE 302 trial, which demonstrated a significant survival advantage over traditional chemotherapy. Patients treated with Tevimbra experienced a median overall survival of 8.6 months, compared to 6.3 months for those on chemotherapy.

The drug has already received approval in Europe for the same condition and is under review for additional indications, including first-line ESCC treatment and as a therapy for non-small cell lung cancer. BeiGene is also conducting numerous trials to explore Tevimbra broader potential across various cancer types, with over 900,000 patients worldwide already treated.

Initially, BeiGene and Novartis collaborated on developing Tevimbra under a 2021 agreement that allowed Novartis to lead regulatory efforts and commercialize the drug worldwide post-approval. They've now amended this arrangement, granting BeiGene exclusive global rights to develop, manufacture and sell Tevimbra.